# K190064: nView system 1

- Pathway: 510(k) (Traditional)
- Applicant: Nview Medical, Inc.
- Decided: Jul 8, 2019 after 174 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003266 (2000). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142740: Ziehm Vision RFD 3D, Ziehm Imaging GmbH (2015) Summary page 4.

## Most influential descendants
- K211064: nView s1 with nav option (2021), 1 descendant of its own
- K221344: nView s1 with nav option (2022), 0 descendants of its own

## Indications for use
nView system 1 is intended to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. The device is indicated to image human anatomy up to 30 cm thickness. The device is not indicated for mammographic or lung nodule applications.

Source page: https://510kreport.com/device/K190064
Methodology: https://510kreport.com/methodology